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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA FIBER-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE

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RICHARD WOLF GMBH COBRA FIBER-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE Back to Search Results
Model Number 7326071
Device Problem Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/07/2020
Event Type  Injury  
Manufacturer Narrative
Rwmic will reach out to the user facility and the manufacturer to gather additional information. Upon receipt of new information, a follow-up report will be submitted.
 
Event Description
It was reported that the device was "inserted into penis and while inside it fell apart. They had to go back in and retrieve what parts they could find. Caused delay and possible harm to patient since they don't know if they retrieved all the parts. Rwr-6/1/20 new 12/12/16 they were using a laser during the procedure. The initial reporter called back later and confirmed they didn't use a laser when this was inside the patient. They used it afterwards. The initial reporter also reported on the medwatch questionnaire: potential patient harm due to black covering at the scope tip sloughing off inside of patient's ureter. Small black pieces retrieved. Scope handed off sterile field to spd cnoic. Will the device be returned? yes. Was the device being used on a patient when the reporting issue occurred? yes. Was there any injury or illness to the patient due to the reported issue? yes. Was there any injury or illness to any other personnel due to the reported issue? no. Did the issue cause a delay in the procedure being performed? yes. Did the delay put the patient at risk? yes. Was there a similar back-up device available for use? yes. Was the scheduled procedure completed? yes.
 
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Brand NameCOBRA
Type of DeviceFIBER-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimer strasse 32
knittlingen, 75438
GM 75438
MDR Report Key10397455
MDR Text Key202693489
Report Number1418479-2020-00020
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7326071
Device Catalogue Number7326071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2020
Distributor Facility Aware Date08/07/2020
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer08/11/2020
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/12/2020 Patient Sequence Number: 1
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